Insulin ResistancePhase 2/3NCT01666665
Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin
A Phase 2/3 study testing Metformin and Sugar pill in people with Insulin Resistance and Hypermetabolism, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Insulin Resistance, Hypermetabolism, Hyperglycemia
- What is being tested?
- Metformin and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 23 Apr 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient age 10-19
- Primary diagnosis of ≥ 20 Total Burn Surface Area Burn (TBSAB )
Who cannot join
- Decision not to treat due to burn injury severity
- Known history of AIDS, ARC, HIV
- Pregnancy
- Previous diagnosis (pre -burn) of renal failure, liver disease or hepatic dysfunction- Serum Creatinine >1.5mg/dL for males and >1.4mg/dL for females, after fluid resuscitation (Clinical definition of kidney damage)
- Pre-existing type 1 diabetes mellitus
- Pre Existing type 2 diabetes mellitus and receiving treatment
- Allergies to Metformin
- Acute or chronic acidosis (lactic or any other metabolic type) and renal failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Galveston, Texas, 77551
About this study
Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Insulin and metformin have demonstrated anabolic activity with minimal associated side effects. However, it is unknown whether the beneficial effects arise from tight euglycemic control or direct effect of insulin action. We hypothesize that during acute hospitalization, administration of metformin at a dose titrated to maintain blood glucose between 80-180 mg/dl will accelerate wound healing and recovery in children with severe thermal injury and will have beneficial long-term effects on muscle strength, immune function, and wound healing.
Read the detailed description
Metformin treated patients will be compared to control patients. Both groups will receive insulin therapy for blood glucose >180mg/dl. Insulin will be titrated according to hospital sliding scale.
The use of insulin or metformin will benefit burned children by improving muscle protein build-up, speeding wound healing and reversing growth arrest, improving the immune response, and positively affecting long-term rehabilitation.
The results of this study may initiate a change in standard of care as it is found that simply the reduction of blood glucose by metformin, improves patient outcomes as metformin can be administered without the added complication of hypoglycemia.
- Conditions
- Insulin Resistance, Hypermetabolism, Hyperglycemia
- Being tested
- Metformin, Sugar pill
- Keywords
- Burn
- Medical subject headings
- Insulin Resistance, Hyperglycemia, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called glucophage
Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months
Sugar pillDrug
Also called placebo
Sugar pill up to 3 times per day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| metformin | Active comparator | Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months Receives: Drug: Metformin |
| Sugar pill | Placebo comparator | sugar pill up to 3 times per day for 12 months Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
As measured by OGTT
Measured: Measure changes between admission and 2 years post burn
Secondary outcomes (2)
Protein synthesis
As measured by stable isotope infusion study
Measured: Measure changes between admission and 1 years post burn
Morbidity
As measured by Organ Failure assessments
Measured: Measure changes between admission and 2 years post burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2018
- Study completion23 Apr 2019
Why it stopped: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666665
- Sponsor's protocol ID
- 12-142
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2012
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin
- ClinicalTrials.gov ID
- NCT01666665
- Acronym / sponsor ID
- 12-142
- Conditions
- Insulin Resistance, Hypermetabolism, Hyperglycemia
- Keywords
- Burn
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- Nov 2012 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Insulin and metformin have demonstrated anabolic activity with minimal associated side effects. However, it is unknown whether the beneficial effects arise from tight euglycemic control or direct effect of insulin action. We hypothesize that during acute hospitalization, administration of metformin at a dose titrated to maintain blood glucose between 80-180 mg/dl will accelerate wound healing and recovery in children with severe thermal injury and will have beneficial long-term effects on muscle strength, immune function, and wound healing.
Detailed description
Metformin treated patients will be compared to control patients. Both groups will receive insulin therapy for blood glucose >180mg/dl. Insulin will be titrated according to hospital sliding scale.
The use of insulin or metformin will benefit burned children by improving muscle protein build-up, speeding wound healing and reversing growth arrest, improving the immune response, and positively affecting long-term rehabilitation.
The results of this study may initiate a change in standard of care as it is found that simply the reduction of blood glucose by metformin, improves patient outcomes as metformin can be administered without the added complication of hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin | Active comparator | Drug: MetforminMetformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months |
| Sugar pill | Placebo comparator | Drug: Sugar pillsugar pill up to 3 times per day for 12 months |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient age 10-19
- Primary diagnosis of ≥ 20 Total Burn Surface Area Burn (TBSAB )
Key exclusion criteria (8 listed)
- Decision not to treat due to burn injury severity
- Known history of AIDS, ARC, HIV
- Pregnancy
- Previous diagnosis (pre -burn) of renal failure, liver disease or hepatic dysfunction- Serum Creatinine >1.5mg/dL for males and >1.4mg/dL for females, after fluid resuscitation (Clinical definition of kidney damage)
- Pre-existing type 1 diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: glucophageMetformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months | Drug | metformin |
| Sugar pillAlso: placeboSugar pill up to 3 times per day for 12 months | Drug | Sugar pill |
Primary outcome
Insulin resistance
Time frame: Measure changes between admission and 2 years post burn
As measured by OGTT
2 secondary outcomes
Protein synthesis
Time frame: Measure changes between admission and 1 years post burn
Morbidity
Time frame: Measure changes between admission and 2 years post burn
Results and safety
The study was stopped early (reason given: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David N Herndon, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin and Sugar pill in people with Insulin Resistance and Hypermetabolism, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: Measure changes between admission and 2 years post burn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.